Kornimate/medical-research-clean huggingface dataset:
phase 3 study to evaluate safety and efficacy of iclaprim versus vancomycin for absssi: revive-2

Conditions: Skin Structures and Soft Tissue Infections

Summary: this is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

this is a multicenter, randomized, double-blind study of the efficacy and safety of iv iclaprim compared to iv vancomycin. patients will receive either iclaprim or vancomycin for 5 to 14 days. patients will be evaluated daily up to early time point (etp), then every 48 to 72 hours through the end of treatment. patients will also be evaluated at the test of cure (toc) visit (7 to 14 days post-eot), and will have a late follow-up (lfu) visit (28 to 32 days post-first dose).

Eligibility criteria:
inclusion criteria: 1. written informed consent; 2. ≥18 years of age; 3. a bacterial infection of the skin with a lesion size area of at least 75 cm2; 4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections; 5. the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain). exclusion criteria: 1. severely impaired arterial blood supply such that amputation of the infected anatomical site is likely; 2. infected diabetic foot ulcers; 3. infected decubitus ulcers; 4. necrotizing fasciitis or gangrene; 5. uncomplicated skin or skin structure infection; 6. infections associated with a prosthetic device; 7. suspected or confirmed osteomyelitis; 8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.
antipsoriatic effect of a topical formulation for the treatment of psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: the current most important topical treatments for psoriasis are vitamin d3 analogues and/or corticosteroids. the possibility of another effective treatment for psoriasis could be based on the immunosuppressive efficacy of selective blockers of a lymphocyte potassium channel. the aim of the clinical trial is to evaluate the safety, tolerability and anti-psoriatic efficacy of topical sps4251 formulations in comparison to placebo and to a marketed topical vitamin-d analogue ointment in a psoriasis plaque test.


Eligibility criteria:
inclusion criteria: * men aged 18 years or older * subjects with mild to moderate psoriasis vulgaris in a chronic stable phase * subject with up to three stable plaques with an area sufficient for five treatment fields * plaques to be treated should have a comparable thickness of the echo lucent band of at least 200 µm exclusion criteria: * subjects with guttate psoriasis, punctate psoriasis, erythrodermic psoriasis, psoriatic arthropathy and pustular psoriasis * local treatment with antipsoriatics in the 4 weeks preceding and/or during the trial, and any topical antipsoriatic treatment on the plaques to be treated in this trial in the 8 weeks before first treatment and/or during the trial * systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics, retinoids in the three months before first treatment and during the trial; * treatment with systemic medications or medications acting locally which might have countered or influenced the trial aim * contraindications according to summary of product characteristics of daivonex® ointment; * uv-therapy within four weeks before first treatment and during the trial * symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before baseline visit and during the trial * any history of cardiovascular disease * any evidence of ecg abnormality on screening ecg * close affiliation with the investigator (e.g. a close relative) or persons working at bioskin gmbh or subject is an employee of the sponsor; * subject is institutionalized because of legal or regulatory order.
perineural dexamethasone on the duration of popliteal nerve block for anesthesia after pediatric ankle surgery

Conditions: Ankle Disease; Ankle Injuries; Foot Injury; Foot Diseases

Summary: effect of perineural dexamethasone on the duration of popliteal nerve block for anesthesia after pediatric ankle/foot surgery.

this study is proposed to explore the effect of systemic dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery. after foot and ankle surgery, children need good analgesia. peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. the safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. an effective adjuvant, such as dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect. there is considerable research where intravenous and perineural dexamethasone use has been compared in adults. however, there is a massive lack of research regarding children. in this study, investigators compare different doses of perineural dexamethasone. groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic. the investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously covers the need for good pain relief and fast recovery postoperatively.

Eligibility criteria:
inclusion criteria: * children scheduled for hand/wrist surgery * body weight \> 5kg exclusion criteria: * infection at the site of the regional blockade * coagulation disorders * immunodeficiency * asa= or \>4 * steroid medication in regular use
a novel approach to endometrial preparation in recipients of donor eggs

Conditions: Implantation, Embryo

Summary: this study compares two different methods to prepare the uterine lining of recipients for implantation in cycles using donor eggs. the study method requires less time than the standard method. it is hypothesized that both methods would be suitable for use in egg donor cycles.

currently a combination of medications is used to prepare the uterine lining of recipients for implantation in egg donor cycles. the protocol used most commonly is as follows: initially the individual's own pituitary-ovarian system is suppressed using a gnrh agonist so there are not conflicting signals sent to the uterus. this is followed by hormonal medication identical to what is secreted by the ovaries to prepare the uterine lining for subsequent embryo transfer in donor egg cycles.this preparation typically takes a minimum of four weeks. this study will compare a different medication, a gnrh antagonist (which is commonly used in ivf) to suppress an individual's system during the preparation of the uterine lining. this protocol would generally take only two weeks to prepare the uterine lining.

Eligibility criteria:
inclusion criteria: * recipients awaiting egg donation * some ovarian function * normal endometrial cavity exclusion criteria: * submucosal myoma * myoma(s) greater than 4 centimeters * endometrial polyp * des exposure * documented recalcitrant thin endometrium ( \<7 mm) * untreated vulvovaginitis * active pelvic infection * endometrial cancer or suspected/known hormonally sensitive cancers * breast cancer * thromboembolic disease * cerebrovascular or coronary heart disease * diabetes mellitus * hepatic tumors or active liver disease * severe hypertension * headaches with neurologic disease * cholestatic disease * heavy smoking over age 35

Keywords: donor eggs donor oocytes pregnancy embryo implantation infertility ivf
the effect of exercise and metformin on carotid intima-media thickness in patients with prediabetes

Conditions: Pre Diabetes; Exercise; Metformin; Atherosclerosis

Summary: the aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.

the researchers think that the application of guide-based exercise programs in prediabetes patients will decrease the carotid intima-media thickness.the aim of this study is to evaluate whether there is a change in carotid intima media thickness with the application of guide-based exercise programs in individuals with prediabetes, and to evaluate whether there is a difference between the group in which exercise programs were applied and those who received only lifestyle change and metformin.

Eligibility criteria:
inclusion criteria: * leading a sedentary life * those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers) * have the same weight for 6 months before participating in the study (±2.5 kg) * those diagnosed with prediabetes by oral glucose tolerance test and/or hba1c measurement exclusion criteria: * serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training. * having cardiovascular disease * being diabetic * using metformin before participating in the study * receiving hormone replacement therapy * life expectancy less than 1 year * hiv positivity * substance use * functional dependency * cognitive weakness * those who have other diseases that will affect the results of the study (respiratory diseases, muscle diseases, etc.) * those who use drugs or supplements that will affect the results of the study

Keywords: prediabetes exercise metformin atherosclerosis
effect of hyaluronic acid on oral mucosal wound healing - focus on pain and re-epithelisation

Conditions: Soft Tissue Wound Healing

Summary: establishment of a sufficiently wide and thick keratinized gingival/mucosal tissue cuff around teeth/implants is considered of importance for long-term stability. this can more readily be achieved by means of autogenous soft tissue grafts harvested from the palate than with soft tissue substitutes. however, this often implies the creation of an open palatal wound involving secondary intention healing. the aim of this randomized controlled, split-mouth, clinical trial is to assess the effect of a hyaluronic acid containing commercial product on wound healing and patient morbidity after palatal soft tissue harvesting. altogether, 20 volunteers will be recruited. an individualized splint containing 2 symmetrically located contralateral cylindrical openings will be used for standardized soft tissue harvesting (6 mm in ø, 2 mm in depth). soft tissue grafts will be harvested randomly from the right or left side and patients will be monitored for 3 weeks followed by a 1-month wash-out period prior to harvesting the second soft tissue graft from the other side. participants will randomly start treating the palatal wound either with the test product (gum aftaclear gel, sunstar suisse sa, etoy, switzerland; 0.3%) or saline solution for 7 days to promote the healing process, which will be reversed for the second round. patient-related outcomes (morbidity, discomfort, taste alteration, pain killer consumption), frequency of bleeding events, defect closure (area, volume), and microbial colonisation will be recorded and analysed for any differences between the control and test product. further, in 6 additional volunteers, biopsies of the healing wound are collected in a similar fashion as described above, but with the use of a larger stent in order to harvest also pristine surrounding tissues for histological analysis; biopsies are collected up to 14 days of healing.


Eligibility criteria:
inclusion criteria: * age 18-65 years, * systemically healthy, * healthy periodontal conditions at the experimental region or conditions not interfering with proper biopsy harvesting, * no known sensitivity to hy, * no uncontrolled diabetes mellitus, * no radiotherapy or chemotherapy, * no current pregnancy or breastfeeding, * no hormonal diseases, * no infectious diseases, * no autoimmune diseases or under immunotherapy, * no systemic bone disease, * no wound healing disorders or acute inflammatory/infectious processes, * no systemic diseases with implications on mucous membranes (e.g., morbus crohn), * no increased risk of bleeding (i.e., patient with coagulation disorders or under anticoagulant therapy, and * no heavy smokers (i.e., no regular tobacco consumption \> 10 cigarettes/day). exclusion criteria: * not meeting the inclusion criteria.
role of pet scan in the evaluation of early response to maintenance treatment in advanced non-small-cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: non small cell lung cancer is the first cause of cancer related death in france and is becoming an increasing health problem in developing countries. recently for patient with no progression disease after first line chemotherapy, new therapies were validated in maintenance (bevacizumab) or switch maintenance treatment (erlotinib, pemetrexed) with improved survival. until now, determination of efficiency of treatment is only based on morphological response (recist) and remains inappropriate to such cytostatic drugs for which there is no anatomical lesion modification. nuclear medicine and especially 18-fdg positron emission tomography (pet) offers a biologically relevant tool for assessment of tumour response therapies. the assumption of the study is that fdg pet would allow to earlier detect a lack of response, thereafter, to modify an ineffective treatment. indeed, nowadays the treatment is maintained up to evidence of progression disease. however, despite the increasing use of fdg pet for predicting therapeutic response, there are no validated criteria for judging response of maintenance therapy in non-small cell lung cancer. it seems necessary to determine standardized criteria response, earlier during the course of maintenance therapy in patient with non small cell lung cancer. the final aim is to optimize survival by an adapted metabolic imaging guided therapy.

the purpose of the study is to optimize survival by an adapted metabolic imaging therapy in patients with advances non-small cell lung cancer. the primary objective of the study is to evaluate the role of suv and metabolic volume measured by fdg petscan in the early prediction of treatment response. 80 patients will be included in 2 years. they will be follow up for one year for monitoring the progression free survival.

Eligibility criteria:
inclusion criteria: * age superior to 18 years old * effective contraception method or negative pregnancy test at the inclusion * oms inferior or equal to 1 * non-small cell lung cancer stage iiib or iv * non progressive disease after at lest 4 cycles of platinum-based chemotherapy * eligible fo maintenance therapy with bevacizumab and/or pemetrexed * inform consent signed exclusion criteria: * evolution of a second cancer in the 3 years before inclusion * pregnancy or breast-feeding * poorly controlled diabetes * curatorship or guardianship * contraindication to iodinated contrast agents * participation to another clinical research with an experimental drug * impossible decubitus * not possibility to follow-up the procedures of the study due to geographic, social or psychic reasons

Keywords: lung cancer, pet, progression free survival
an observational, non-interventional trial to assess patient satisfaction and safety of subsys™ spray.

Conditions: Breakthrough Pain

Summary: chronic pain patients who experience breakthrough pain in the background of controlled persistent pain with opioids will be followed for 3 months in order to assess the safety and titration trends in the clinical practice setting of a novel fentanyl sublingual spray (subsys™) for the treatment of breakthrough pain.

approximately 100 subjects across 10 centers throughout the united states will be enrolled into the study. subjects who are currently taking actiq® for their breakthrough pain and will be discontinued due to lack of efficacy, poor tolerability, patient or prescriber dissatisfaction and meet all other study inclusion criteria and none of the exclusion criteria will be candidates to receive a sublingual fentanyl spray (subsys™). the total duration of the study for each subject will be no more than 4 months.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age. * subjects who are experiencing 1-4 episodes of break through pain per day in spite of optimized background analgesia and who have taken at least 60 mg/day of morphine (or equivalent analgesic) for at least 7 days. * who are currently using actiq® for their breakthrough pain and are being discontinued due to lack of efficacy, side effects, patient dissatisfaction or prescriber dissatisfaction with treatment. * are able to follow and complete all necessary study procedures. * are willing and able to give written informed consent before participating in the study. * enrolled in the class wide rems as verified by the study personnel. exclusion criteria: * subjects who are not opioid tolerant. * using a rapid onset opioid other than actiq® to manage their breakthrough pain. * have physical abnormalities of the floor of the mouth that could affect absorption as determined by investigator. * are subjects with uncontrolled or rapidly escalating pain. * are subjects with a history of alcohol or substance abuse within the last 3 years. * have a clinically significant medical history (past or present) of any disease that would compromise the study or the well-being of the subject. * are subjects who have participated in another clinical trial with an analgesic within the last month. * are female subjects with a positive pregnancy test or who are currently lactating. * are subjects who are taking medications that are known inhibitors of the cyp3a4 isozyme, such as ketoconazole. * are subjects who have taken a monoamine inhibitor within 14 days before a dose of study medication. * opioid being used for chronic migraine or acute pain. * are subjects who are unsuitable for inclusion for any other reason, in the opinion of the investigator.

Keywords: breakthrough pain subsys fentanyl opioid persistent pain
perineal massage performed during the labour

Conditions: Delivery Problem; Childrearing; Satisfaction, Patient; Perineum; Injury; Perineal Tear; Pain, Labor

Summary: in this study, perineal massage was applied to primiparous women who did not give birth before, as a quasi-experimental control group to determine the effects of massage on birth comfort, perineal trauma and perineal pain.

in this study, perineal massage was applied to primiparous women who did not give birth before, as a quasi-experimental control group to determine the effects of massage on birth comfort, perineal trauma and perineal pain. perineal massage was administered to all pregnant women in the experimental group during both the labor and resting phases between contractions. the participants received an average of 5-10 minutes of perineal massage two, four and four to six times at the latent (0-3-cm cervical dilation), active (4-7-cm cervical dilation) and transition (8-10-cm cervical dilation) phases of labor, respectively. these women continued to receive perineal massage at every push throughout the second stage of labor. before perineal massage, the researcher wore sterile gloves, placed two fingers into the 3-4-cm wide-open vagina and applied vaseline routinely to lubricate the vagina in the delivery room. . perineal massage was applied using all three of the "from one edge to the other", "u shape" and "pressure" massage techniques. the researcher gently applied a rhythmic "u" pressure with both fingers, moving them on the vagina downwards about 3 to 9 o'clock. each pressure movement was maintained laterally for 1-2 minutes towards the rectum.

Eligibility criteria:
inclusion criteria: * having no complications for vaginal delivery * having no dystocia affecting the birth process (e.g., prolonged labor, precipitate labor, shoulder dystocia) * having a singleton pregnancy, * having a fetal head with an anterior cephalic position, * being at the latent phase of labor, * having no perineal scar tissue, * having no diagnosis of vaginal fungus or infection, * having a fetus with a birth weight between 2500 and 4000 g, * having no communication problems. exclusion criteria: -all pregnant women who developed fetal distress during labor or had to undergo cesarean delivery were excluded from the study.

Keywords: childbirth comfort perineal massage perineal tear perineal pain midwifery
a drug utilisation post-authorisation study of new users of aclidinium bromide (monotherapy or in combination)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: dus1 and dus2 are descriptive drug utilisation studies in new users of aclidinium bromide in europe. the objectives of dus1 and dus2 are to describe the characteristics and patterns of use of new users of aclidinium bromide (monotherapy or in combination) and new users of other medications for chronic obstructive pulmonary disease (copd); to evaluate the potential off-label use of aclidinium bromide; to describe users of aclidinium bromide in subgroups of patients for whom there is missing information in the risk management plan (rmp); and to establish a core cohort of new users of aclidinium bromide for the future evaluation of safety concerns described in the rmp. the data source for these studies will be the crpd in the uk, the gepard in germany, and national health databases in denmark.

dus1 will be conducted when the target number of new users of aclidinium monotherapy is reached, and dus2 when the target number of new users of aclidinium fixed-dose combination with formoterol is reached. as this was a descriptive study no primary or secondary endpoints were specified.

Eligibility criteria:
inclusion criteria: * patients in the study will be required to meet the following criteria, as ascertained from each of the automated databases: * to have at least 1 year of enrolment in the database (dus1 and dus2). * to have not been prescribed aclidinium bromide as monotherapy or with concomitant use of formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in dus1 * to have not been prescribed aclidinium bromide as monotherapy, with concomitant use of formoterol, or as aclidinium/formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in dus2 the same inclusion criteria will be applied for each of the comparator drugs. exclusion criteria: * no age restrictions or exclusion criteria will be applied. this will allow for the characterisation of all users of aclidinium bromide and comparator drugs irrespective of the indication for which these medications are used. identification of potential off-label use of aclidinium bromide in the paediatric and adult populations is one of the specific objectives of this dus.

Keywords: copd